1. Comparative Safety of Originator and Biosimilar Epoetin Alfa Drugs: An Observational Prospective Multicenter Study
- Author
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Stoppa, Giovanna, D’Amore, Carmen, Conforti, Anita, Traversa, Giuseppe, Venegoni, Mauro, Taglialatela, Maurizio, Leone, Roberto, Messa, Michele Giuseppe, Petrolino, Alessandro, Cavallini, Lucia, Fiorini, Fulvio, Guarda, Laura, Lidestri, Vincenzo, Toffoletto, Pierpaolo, Rebeschini, Mirca, Cantaro, Salvatore, Paciolla, Adriana, Spinello, Michela, Tarroni, Giovanni, Bertoli, Massimo, Lentini, Paolo, Gatti, Pier Luigi, Garibotto, Giacomo, Brigante, Maurizio, Bolasco, Piergiorgio, Opri, Sibilla, Zocca, Margherita, Michielan, Silvia, Bisso, Ilaria, Russo, Claudio, Ambrosino, Paolo, Businco, Fabrizio, Stoppa, G, D'Amore, C, Conforti, A, Traversa, G, Venegoni, M, Taglialatela, M, Leone, R, and ESAVIEW Study, Group
- Subjects
Male ,medicine.medical_specialty ,Anemia ,Erythropoiesis-stimulating agents (ESAs) ,medicine.medical_treatment ,030232 urology & nephrology ,Peritoneal dialysis ,03 medical and health sciences ,0302 clinical medicine ,Renal Dialysis ,chronic renal failure ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Original Research Article ,Prospective Studies ,030212 general & internal medicine ,Renal Insufficiency, Chronic ,Prospective cohort study ,Biosimilar Pharmaceuticals ,Dialysis ,Aged ,Pharmacology ,Biotechnology, Pharmacology, Pharmacology (medical) ,business.industry ,prospective study, anemia , chronic renal failure, Erythropoiesis-stimulating agents (ESAs) ,Epoetin alfa ,Biosimilar ,General Medicine ,Middle Aged ,medicine.disease ,anemia ,Epoetin Alfa ,Transplantation ,Treatment Outcome ,Female ,Hemodialysis ,business ,medicine.drug ,prospective study ,Biotechnology - Abstract
Background Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007. Aim This study aimed to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. Methods A prospective study was conducted in four Italian regions between 1 October 2013 and 30 June 2015. The study population included patients aged ≥ 18 years undergoing hemodialysis and treated with epoetins as per the clinical practice of the participating centers. The two comparison cohorts included patients treated with either an originator or a biosimilar epoetin alfa. Each patient was followed up until occurrence of any safety outcome of interest (grouped into three major categories), switch to a different ESA product, transplant or peritoneal dialysis, death, or end of the study period, whichever came first. Results Overall, 867 subjects were included in the study (originator: N = 423; biosimilar: N = 444). Biosimilar users were older than originator users (median age of 76 vs 64 years, respectively), more frequently affected by arrhythmia (29.3 vs 22.5%), and less frequently candidates for transplantation (3.8 vs 18.2%). Cox-regression analysis showed no increase in risk of safety outcomes in biosimilar users, even after adjusting for confounding factors: 1.0 (95% confidence interval [CI] 0.7–1.3) for any outcomes; 1.1 (95% CI 0.7–1.8) for problems related to dialysis device; 0.9 (95% CI 0.6–1.5) for cardio- and cerebro-vascular conditions; 0.9 (95% CI 0.6–1.5) for infections. Conclusion This study confirms the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis. Electronic supplementary material The online version of this article (10.1007/s40259-018-0293-2) contains supplementary material, which is available to authorized users.
- Published
- 2018